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Splintline

by Lang Dental Manufacturing Company, Inc. 3 variants

Ref 2070I69

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++D650146Z Basic UDI-DI D6502070I690UDI-DIDate21 Jan 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Provisional Crown and Bridge Acrylic
Model / Reference
2070I69
Primary DI / UDI-DI
D6502070I690
Basic UDI-DI
++D650146Z
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
Device Class
Class I
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
US-MF-000003646
Authorised representative
MediMark Europe Sarl. FR-AR-000000182

Other devices from Lang Dental Manufacturing Company, Inc.

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No